Healthy Parents - Healthy Children. Weight Loss Before Fertility Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Weight loss
研究概览
简要总结
The detrimental effect of overweight and obesity on fecundity has been well documented.
The investigators wish to investigate the intervention program for weight loss before fertility treatment.
Subsequently to gain knowledge on the effect of overweight/obesity and weight loss on the vaginal microbiome, on DNA damage on sperm cells, on the occurrence of endocrine disruptors in the endometrium, and on the gene expression in the endometrium.
详细描述
Purpose and aim of the study The Fertility Clinic at Zealand University Hospital wishes to introduce a new care concept: 'Healthy Parents - Healthy Children´ with the purpose of changing the behaviours of infertile men and women towards a healthier life style now and for future generations.
The Zealand Region includes areas of significant deprivation compared to Copenhagen and has a higher prevalence of obesity and poor diet.
These inequalities generate socio-demographic and long-term health challenges, decrease the chance of becoming pregnant and increase risk of life style related diseases for parents and their offspring in the long term.
The waiting time before fertility treatment (12 months in the region) represents a unique window of opportunity to encourage long-term life style changes. The aforementioned reasons initiated the planned Preconception Clinic 'Healthy Parents - Healthy Children´.
The Preconception Clinic utilises waiting list time to optimise parental health prior to conception. We will provide weight loss interventions aimed at helping the patients to a healthier lifestyle, an increased chance of conception and a decreased risk of life style diseases for themselves and their future offspring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referred to The Fertility Clinic, Zealand Region
排除标准
- •Unable to speak and read Danish
结局指标
主要结局
Weight loss
时间窗: 6 month
The change in weight (in kilograms) from baseline to the 6 month
次要结局
- Change in the semen quality 1(6 months)
- Change in the semen quality 3(6 months)
- Numbers of life births(From 9 month after inclusion)
- Change in the semen quality 2(6 months)
- Change in the semen quality 4(6 months)
- Change in the DNA fragmentation index (DFI)(6 months)
- Numbers of achieved pregnancy(Gestational week 4-8)
- Change in the gene expression of gene involved in implantation(6 months)
- Change in the vaginal microbiome(6 months)
- Change in the occurence of synthetic endocrine disruption chemicals (EDCs)(6 month)
- Change in MicroRNA(6 months)